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The Clinical Laboratory Improvement Amendments of 1988 (CLIA) strengthened and extended quality requirements for labs that perform tests to diagnose or treat disease. About 36,000 labs that perform certain complex tests must be surveyed biennially by either a state or one of six private accrediting organizations. CMS oversees implementation of CLIA requirements and the activities of survey organizations. GAO was asked to examine (1) the quality of lab testing; (2) the effectiveness of surveys, complaint investigations, and enforcement actions in detecting and addressing lab problems; and (3) the adequacy of CMS's CLIA oversight.

Because of limited comparable data from CMS and survey organizations, too little is known about the quality of lab testing. For example, a standardized assessment of lab quality across survey organizations is not possible because of different definitions of what constitutes a serious quality problem. One survey organization had no systematic way of identifying the problematic labs it inspects. However, GAO's analysis of an indicator that measures a lab's ability to consistently produce accurate test results suggests that lab quality may not have improved at hospital labs in recent years. Based on an analysis of available data and interviews with CMS and survey organizations, real and potential lab quality problems are masked by survey, complaint, and enforcement weaknesses. Because most survey organizations announce the timing of biennial surveys, allowing labs to prepare for inspections, surveys may not provide a realistic picture of lab quality. Although two survey organizations that generally inspect hospital labs plan to begin unannounced surveys in 2006, they may not be possible at physician office labs that have irregular hours. Survey organizations that typically inspect such labs, however, provide more advance notice about upcoming inspections than CMS allows states to provide. Several other factors suggest that surveys and complaints do not present a realistic picture of lab quality. Interviews with officials from a sample of states confirmed that some survey organizations do not cite all serious deficiencies, as evidenced by variability in the limited available lab survey data. Officials said that surveyors may be reluctant to cite deficiencies because they view their role as educational, not regulatory; moreover, CMS has instructed state surveyors not to cite some deficiencies for over 2 years after implementing new lab requirements. Finally, lab workers may file complaints infrequently because of concern about retaliation and a lack of understanding about how to file a complaint. CMS rarely imposes sanctions, even for labs with the same repeat deficiencies, a reflection of the educational focus of the CLIA program. CMS does not require labs to participate in a key quality assurance test as frequently as CLIA requires. Although funded by lab fees, CMS officials indicated that the program has not been allowed to hire sufficient staff to carry out the agency's oversight responsibilities. Moreover, CMS's principal oversight tool, intended to determine if all serious deficiencies were identified, lacks independence because many oversight reviews are conducted simultaneously with survey organizations. CMS's presence may make surveyors more attentive to survey tasks than when they are not being observed. Compared to independent reviews, simultaneous reviews rarely identify missed deficiencies. Furthermore, CMS does not collect and analyze data on serious deficiencies identified by each survey organization and thus, is unable to assess whether lab quality is improving or declining. Nor does CMS effectively analyze other key data such as the use of sanctions. To improve oversight, CMS is establishing a nationwide complaints database. CMS is also instituting annual survey organization performance reviews.

Recommendations for Executive Action

Status: Closed - Implemented

Comments: CMS has made progress but is still working to fully implement this recommendation. In 2006, CMS asked accrediting organizations to link their most frequently cited deficiencies back to CLIA standards. On a bi-annual basis CMS meets with all partners, including accrediting organizations; at such meetings, CMS has been working to implement this recommendation. They began by working inductively to develop examples of serious problems at labs--problems that raise red flags. They plan to use these examples to develop definitions of serious problems to which all survey organizations can agree. CMS acknowledged that this effort will lead to greater oversight of accrediting organizations and that accrediting organizations do not welcome this oversight. In April 2007, CMS asked survey organizations to provide information on their top 10 deficiencies and top 10 serious deficiencies cited in CY 2006, along with their corresponding CLIA regulation. To facilitate comparisons, these deficiencies were mapped to the Clinical Laboratory Standards Institute's Quality Systems Essentials. According to CMS officials, the agency is making real progress in refining their method to make meaningful comparisons across survey organizations. They noted that the process for collecting and comparing survey findings will continue indefinitely.

Recommendation: To enable CMS to track the nature and extent of lab quality problems across survey organizations, the CMS Administrator should work with exempt-state programs and accrediting organizations to standardize their categorization and reporting of survey findings in a way that tracks to CLIA inspection requirements and allows for meaningful comparisons across organizations, such as the analysis of trends in the citation of condition-level deficiencies.

Comments: CMS has implemented this recommendation. We found that CMS guidance to state survey agencies required them to provide labs no more than 2 weeks advance notice of an upcoming survey. However, states and accrediting organizations were giving labs from 4 to 12 weeks advance notice. Too much advance notice allows labs to prepare for their surveys by cleaning up quality control records. In 2006, CMS required that no more than 2 weeks advance notice be given of an upcoming survey. With the exception of COLA, all other accrediting organizations and exempt state programs have come into compliance. CMS has a commitment from COLA that it will do so in the first quarter of 2008 when it has completed its implementation of a new data system.

Recommendation: To ensure consistency in the oversight of labs by survey organizations, the CMS Administrator should ensure that the advance notice of upcoming surveys provided to physician office labs is consistent with CMS's policy for advance notice provided by state survey agencies.

Comments: CMS has implemented our recommendation by taking steps to ensure the primacy of the regulatory role of surveys. We found that the greater weight that CMS and survey organizations sometimes place on their educational as opposed to their regulatory role may lead to survey findings that do not accurately reflect lab quality. In response to our recommendation, CMS (1) provided a week of training in Sept. 2006 to 261 surveyors and managers that emphasized the importance of consistently citing deficiencies (additional training scheduled for fall 2007), (2) have revised surveyor guidance to stress enforcement and plan to present changes at the fall 2007 training session, and (3) established a consistency work group whose preliminary action plan includes clarifying which survey findings must always be cited. In addition, CMS plans to monitor citations by comparing deficiencies cited and enforcement proposed/imposed prior to and after training. They also believe that the effort to make accrediting organizations (AO) agree to standard definitions of serous deficiencies, the development of AO performance measures, and post validation surveys will allow closer monitoring to help ensure that accrediting organizations are finding problems and citing appropriately.

Recommendation: To ensure consistency in the oversight of labs by survey organizations, the CMS Administrator should ensure that regulation of labs is the primary goal of survey organizations and that education to improve lab quality does not preclude the identification and reporting of deficiencies that affect lab testing quality.

Comments: CMS is taking steps to implement our recommendation to impose appropriate sanctions on labs with consecutive repeat deficiencies in the same requirements, even though it takes a narrower view of what constitutes a repeat deficiency. Consistent with our recommendation, CMS enhanced its data system to assist surveyors in identifying repeat condition-level deficiencies. Additionally, on April 18, 2008, CMS issued procedures for handling repeat deficiencies as part of its State Operations Manual. These procedures prohibit State Survey Agencies from giving laboratories multiple opportunities to correct repeat deficiencies. Additionally, the procedures instruct the survey agencies to refer laboratories that do not correct repeat deficiencies quickly to the CMS Regional Office for possible enforcement action.

Recommendation: To ensure consistency in the oversight of labs by survey organizations, the CMS Administrator should impose appropriate sanctions on labs with consecutive condition-level deficiencies in the same requirements.

Comments: CMS has not yet implemented our recommendation to require labs to prominently display complaint posters instructing lab workers how to file anonymous complaints. In a July 2007 response for an update on the status of this recommendation, CMS said that they lacked the legal authority to mandate labs to display posters. They agreed to follow up with their lawyers to verify this assertion. They plan to take several other steps to increase awareness of complaint processes including: (1) posting fact sheet on the CMS web site on complaint filing (2)adding information on filing complaints to the interpretive guidelines used by surveyors (3) adding complaints received by accrediting organizations to their complaints database and (4) reminding states and accrediting organizations by letter about the importance of complaints. CMS reported that it sent a letter about complaint tracking to accreditation organizations, exempt states, and professional laboratory organizations on November 30, 2007. According to CMS, this letter highlighted the importance of complaint tracking and filing, and encouraged the publication of compliant processes. CMS has also developed a CLIA Brochure on Complaints which was being prepared for release as of September 2008. Once released, CMS anticipates posting the brochure on its website and printing copies for distribution to laboratories. We will continue to monitor implementation of this recommendation. 2009 Update: GAO recommended that CMS require all survey organizations to develop and require labs to prominently display posters instructing lab workers how to file anonymous complaints. CMS determined that this would not be practical and instead is working on publishing a brochure that will be distributed by surveyors to labs, published on the CMS CLIA Web site, and distributed at lab professional meetings. We are closing this recommendation as not implemented.

Recommendation: To ensure consistency in the oversight of labs by survey organizations, the CMS Administrator should require all survey organizations to develop, and require labs to prominently display, posters instructing lab workers on how to file anonymous complaints.

Comments: We will continue to monitor CMS reviews of accrediting organization and exempt state applications to renew their authority to inspect clinical labs. Our report showed that CMS was not reviewing applications prior to the deadlines it set for such reviews. Data provided by CMS in September 2007 showed that this problem continues. AABB's and Washington's authority were reapproved months after they were scheduled to expire. Additionally, AOA's authority expired March 24, 2008; as of September 2008 CMS had yet to complete its review. Similarly, CAP's authority expired September 30, 2007; as of September 2008 CMS had yet to reapprove CAP as outstanding issues remain. August 2009: CMS has fully implemented this recommendation and it is being closed with an accomplishment report.

Recommendation: To improve oversight of labs and survey organizations, the CMS Administrator should ensure that evaluations of exempt-state and accrediting organization inspection requirements take place prior to expiration of the period for which they are approved in order to ensure the continued equivalency of their requirements with CLIA's.

Comments: CMS agreed with the need to ensure that changes to the inspection requirements of exempt states and accrediting organization are reviewed prior to their implementation, as required by regulation. They have taken steps to standardize tracking and reviews during interim approval periods. In 2007, CMS provided a copy of a tracking report that showed some interim changes were approved in a timely manner (within 30 days) while others were not. In September 2008, CMS provided us with information about changes that occurred during the previous 12 months. That data shows that exempt state and accrediting organization changes are still not being approved in a timely manner. We plan to monitor CMS progress in this area over the course of the next year.

Recommendation: To improve oversight of labs and survey organizations, the CMS Administrator should ensure that changes to the inspection requirements of exempt states and accrediting organizations be reviewed prior to implementation, as required by regulation, to ensure that individual changes do not affect the overall CLIA equivalency of each organization.

Comments: CMS has implemented this recommendation. The CLIA program is no longer subject to CMS FTE limits and reductions. In October 2006, CMS approved 5 FTE postings 4 of which have since closed. The 5th position had not yet been posted as of July 30, 2007. CMS is currently in the process of analyzing the adequacy of regional office FTEs for the CLIA program.

Recommendation: To improve oversight of labs and survey organizations, the CMS Administrator should allow the CLIA program to utilize revenues generated by the program to hire sufficient staff to fulfill its statutory responsibilities.

Comments: CMS has implemented our recommendation that they ensure that federal surveyors validate a sufficient number of inspections conducted by each state survey agency to allow a reasonable estimate of their performance. First, CMS compiled baseline data on FY 2006 CLIA federal monitoring surveys (FMS) showing that many state surveyors had no federal oversight of their surveys. According to the data, there were no FMS surveys in six states and not all surveyors in other states had FMS surveys. Second, CMS issued guidance (Survey and Certification Administrative Letter 07-03) requiring at least one federal monitoring validation survey per state surveyor in FY 2007. Rather than specifying that there be a minimum of one independent validation review for each state surveyor, CMS left the decision about the type of validation survey (independent or observational) to the discretion of each regional office based on each surveyor's performance and circumstances.

Recommendation: To improve oversight of labs and survey organizations, the CMS Administrator should ensure that federal surveyors validate a sufficient number of inspections conducted by each state survey agency to allow a reasonable estimate of their performance, including a minimum of one independent validation review for each state survey agency surveyor.

Comments: CMS did not concur with our recommendation that almost all validation reviews of each accrediting organization's surveys be an independent assessment of performance. They plan to take no action even though we reported one accrediting organization's estimate that about one third of its validation reviews were simultaneous rather than independent.

Recommendation: To improve oversight of labs and survey organizations, the CMS Administrator should require that almost all validation reviews of each accrediting organizations' surveys be an independent assessment of performance.

Comments: Consistent with our recommendation, beginning in 2007, CMS initiated the collection of survey findings from all survey organizations, collecting calendar year 2006 deficiency data. Survey organizations finding are standardized using the Clinical and Laboratory Standards Institute (CLSI) Quality Systems Essentials, which facilitates comparison of like deficiencies among different organizations, with a focus on industry standards. CMS will continue to collect and compare survey finding indefinitely.

Recommendation: To improve oversight of labs and survey organizations, the CMS Administrator should collect and routinely review standardized survey findings and other available information for all survey organizations to help ensure that CLIA requirements are being enforced and to monitor the performance of each organization.

Comments: On August 24, 2007, CMS issued a Survey and Certification Letter that, according to CMS officials, establishes new Loss of Accreditation procedures when CLIA certified laboratories lose or change CLIA accreditation status. The officials explained that when loss of accreditation occurs, close coordination and prompt action among accreditation organizations, CMS regional offices, and State agencies (SAs) is required to ensure continuous oversight. The letter was shared with Partners to ensure common understanding of terms and situations requiring action. To enable implementation of the policy, CMS enhanced the CLIA data system to accommodate the reasons for loss of accreditation, as outlined in the letter. However, CMS has yet to complete enhancements of its enforcement database. As such, all enforcement actions, including those taken on laboratories that lose accreditation, continue to be tracked in the existing Enforcement Database. A new Enforcement Database is currently planned but as yet to be implemented.

Recommendation: To improve oversight of labs and survey organizations, the CMS Administrator should establish an enforcement database to monitor actions taken by state survey agencies and regional offices on labs that lose their accreditation.